AGC Biologics Inc.

Form 483 issued February 10, 2023 · Bothell, Washington

Inspection: Feb 2 – Feb 10, 2023
Investigators: Andrew K. Haack· Charles Yuan-Chia Kuo· Megan Dellibovi-Ragheb
Observations: 5
Pages: 15
FEI number: 3000209996

In short: On February 10, 2023, FDA issued a Form 483 with 5 observations to AGC Biologics Inc. in Bothell, Washington (FEI 3000209996) after an inspection that ran Feb 2 – Feb 10, 2023. The investigators were Andrew K. Haack, Charles Yuan-Chia Kuo, Megan Dellibovi-Ragheb, Michael Araneta and Zhong Li.

What FDA observed

Preview: the opening words of each observation

01
Written records of investigations into unexplained discrepancies, the failure of a batch or any of its…
02
Your firm has not established adequate procedural controls to protect the electronic data acquisition and manufacturing…
03
There is a lack of assurance that your drug substance manufacturing operations in Building’ “at the…
04
Standard Operating procedures or work instructions are not…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Andrew K. Haack

12 documents · 2017–2023

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.

The firm

AGC Biologics Inc. history

All 8 documents on file for this site, in date order, with what was cited at each inspection.

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Inspection report for this inspectionFeb 10, 2023$550

AGC Biologics Inc. site file

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Questions about this 483

What did FDA find at AGC Biologics Inc.?

FDA listed 5 observations on this Form 483. The opening words of each observation are shown on this page.

Who inspected AGC Biologics Inc.?

Andrew K. Haack, Charles Yuan-Chia Kuo, Megan Dellibovi-Ragheb, Michael Araneta and Zhong Li are named on this Form 483, for the inspection of Feb 2 – Feb 10, 2023. Each investigator has a profile showing what they cite most.

When was AGC Biologics Inc. inspected by FDA?

The inspection ran Feb 2 – Feb 10, 2023, and the Form 483 is dated February 10, 2023.

How do I get the full Form 483 for AGC Biologics Inc.?

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